An introduction to the in-vitro diagnostics regulation


The course is aimed at those working in in vitro diagnostics and want to learn more about the new IVDR regulation.

In May 2022, the old EU In Vitro Diagnostic Directive (IVDD) was replaced by the new (2017/746) In Vitro Diagnostic Regulation (IVDR) to which the in vitro diagnostic industry is subject.

This course gives you an introduction to the new IVDR regulatory framework, including risk classification of in vitro diagnostic devices, quality management system and technical documentation requirements, and the process of CE marking with a notified body. You will gain knowledge about application areas, risk classification, the role of the Notified Body, the content of the technical documentation including clinical evidence requirements, post-market activities, risk management and safety requirements and different ways of demonstrating compliance with applicable legal requirements. Note: the training covers only IVDR, not IVDD.

After the training, you should have gained knowledge of the IVDR Regulation, the quality management system for in vitro diagnostics, risk classification of IVD devices, technical documentation and notified bodies.